Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability, 64085-64089 [2019-25139]
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[FR Doc. 2019–25160 Filed 11–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4533]
Compounding Animal Drugs From
Bulk Drug Substances; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of draft
guidance for industry (GFI) #256
entitled ‘‘Compounding Animal Drugs
from Bulk Drug Substances.’’ The draft
guidance, if finalized, will describe
FDA’s current thinking about
compounding animal drugs from bulk
drug substances. FDA has generally
exercised enforcement discretion with
regard to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment options exist.
This draft guidance, a continuation of
this practice, is intended to provide
additional information and clarity to
veterinarians and pharmacists about
FDA’s current thinking with respect to
animal drug compounding from bulk
drug substances. FDA previously
published draft guidance on this issue
for public comment in May 2015 (Draft
GFI #230, ‘‘Compounding Animal Drugs
from Bulk Drug Substances’’). We
received over 150 comments on that
draft guidance. Based on those
comments, we decided to withdraw the
SUMMARY:
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May 2015 draft guidance and publish
this draft guidance for public comment.
DATES: Submit either electronic or
written comments on the draft guidance
by February 18, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the proposed collection of
information by February 18, 2020.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–4533 for ‘‘Compounding
Animal Drugs From Bulk Drug
Substances.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
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Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
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made publicly available, submit your
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with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance: Eric
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Nelson, Division of Compliance (HFV–
230), Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
402–7001, cvmcompliance@fda.hhs.gov.
With regard to the proposed collection
of information: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
draft GFI #256 entitled ‘‘Compounding
Animal Drugs from Bulk Drug
Substances.’’ FDA has generally
exercised enforcement discretion with
regard to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment options exist.
This draft guidance, a continuation of
this practice, is intended to provide
additional information and clarity to
veterinarians and pharmacists about
FDA’s current thinking with respect to
animal drug compounding from bulk
drug substances. We previously
announced the availability of a draft
guidance addressing this issue (GFI
#230, ‘‘Compounding Animal Drugs
from Bulk Drug Substances’’) in the
Federal Register of May 19, 2015 (80 FR
28624). In response to the comments
received on GFI #230, we decided not
to finalize that draft guidance, and
instead are issuing draft GFI #256 for
comment. If finalized, this draft
guidance will describe the
circumstances under which, based on
our current understanding of the risks of
animal drugs compounded from bulk
drug substances, FDA does not intend to
take enforcement action against
pharmacies and veterinarians who
compound animal drugs for violations
of the FD&C Act’s requirements for: (1)
Approval; (2) adequate directions for
use; and (3) current good manufacturing
practices.
Elsewhere in this issue of the Federal
Register, FDA is requesting nominations
for bulk drug substances to be included
on the ‘‘List of Bulk Drug Substances for
Compounding Office Stock Drugs for
Use in Nonfood-Producing Animals or
Antidotes for Food-Producing Animals’’
(the List) described in draft GFI #256.
That Federal Register notice describes
information needed by FDA to evaluate
nominations and explains when FDA
will include bulk drug substances on
the List; such nominations will be
collected in a separate docket. The List
is available at https://wcms.fda.gov/
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FDAgov/AnimalVeterinary/Compliance
Enforcement/UnapprovedAnimalDrugs/
ucm596211.htm.
II. Specific Topic for Comment
In addition to any other comments on
the draft guidance, we are specifically
requesting comments on section III.A.5
of the draft guidance. That section
provides that if a compounded drug
contains the same active moiety as a
marketed FDA-approved, conditionally
approved, or indexed animal drug or an
FDA-approved human drug but as a
different salt, ester, or other noncovalent
derivative, there should be a difference
between the compounded drug and the
FDA-approved, conditionally approved,
or indexed animal drug or FDAapproved human drug that will produce
a clinical difference in the patient and
the medical rationale is documented in
the prescription, or if a veterinarian is
compounding the drug, the medical
rationale is noted in the patient’s
medical record.
FDA is concerned that compounding
an animal drug using a different salt,
ester, or other noncovalent derivative of
the same active moiety used in a
marketed FDA-approved, conditionally
approved, or indexed animal drug or
FDA-approved human drug can affect
the absorption, distribution,
metabolism, excretion, and stability of
the compounded animal drug. All of
these factors contribute to a drug’s
safety and effectiveness.
FDA is also concerned that
compounding an animal drug from a
different salt, ester, or other noncovalent
derivative of the same active moiety as
a marketed FDA-approved,
conditionally approved, or indexed
animal drug or FDA-approved human
drug may impact the incentives for
seeking legal marketing status of a new
animal drug (i.e., approval, conditional
approval, or indexing). Unlimited
compounding using a different salt,
ester, or other noncovalent derivative
could cause a disincentive for new
animal drug sponsors to continue to
research and develop innovative new
animal drugs.
However, FDA believes that in some
cases the prescribing veterinarian may
determine that a new animal drug from
a different salt, ester, or other
noncovalent derivative of the same
active moiety as a marketed FDAapproved, conditionally approved, or
indexed animal drug or FDA-approved
human drug will produce a clinical
difference for the identified patient.
Under the draft guidance, a pharmacy
could compound such an animal drug if
the prescribing veterinarian documents
such a determination on the
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prescription, or if a veterinarian is
compounding the drug, the medical
rationale is noted in the patient’s
medical record.
FDA invites public comment on this
issue.
III. Significance of Guidance
This Level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, if finalized,
will represent the current thinking of
FDA on compounding animal drugs
from bulk drug substances. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations
IV. Paperwork Reduction Act of 1995
This draft guidance contains proposed
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3521).
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, we invite comments on these
topics: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information collected;
and (4) ways to minimize the burden of
the information collected on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Compounding Animal Drugs
from Bulk Drug Substances (OMB
Control Number 0910–NEW).
Description of Respondents: The
proposed respondents are pharmacists
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in either State-licensed pharmacies or
Federal facilities, or veterinarians, who
compound animal drugs from bulk drug
substances.
Description: The Center for Veterinary
Medicine has written draft GFI #256 to
address a perceived need for Agency
guidance in its work with the animal
health industry. The draft guidance
describes FDA’s current thinking, based
on our current understanding of the
risks of animal drugs compounded from
bulk drug substances, and describes the
circumstances under which FDA does
not intend to take enforcement action
against pharmacists and veterinarians
who compound animal drugs from bulk
drug substances.
FDA estimates the burden of this
collection of information as follows:
Reporting: The draft guidance
contains no new reporting provisions.
Recordkeeping: The draft guidance
contains a new recordkeeping provision.
Our exercise of discretion is dependent
upon our ability to assess whether the
circumstances under which FDA would
intend to exercise such discretion, as
described in this draft guidance, exist.
FDA staff may use pharmacy and
veterinary records, among other things,
to determine the circumstances
surrounding the compounding activity.
Except with regard to one proposed
item, the routine business records kept
by pharmacists who compound animal
drugs from bulk drug substances and
veterinarians who compound animal
drugs from bulk drug substances, as
well as veterinarians prescribing
compounded animal drugs within a
valid veterinarian-client-patient
relationship, should be adequate to
demonstrate that the circumstances
described in the draft guidance exist.
The draft guidance sets forth
circumstances for the compounding of
animal drugs from bulk drug substances.
Section III.A.4 of the draft guidance
provides that if the compounded drug is
a copy of a marketed FDA-approved,
conditionally approved, or indexed
animal drug or an FDA-approved
human drug, there is a difference
between the compounded drug and the
FDA-approved, conditionally approved,
or indexed animal drug or the FDAapproved human drug that will produce
a clinical difference in the identified
patient and the medical rationale is
documented in the prescription, or if a
veterinarian is compounding the drug,
the medical rationale is noted in the
patient’s medical record. We tentatively
conclude that it is usual and customary
for veterinarians to document their
medical rationale for using such a
compounded product as a matter of
maintaining an adequate medical record
in routine practice; therefore, no burden
has been estimated for the time it would
take for a veterinarian to make this
record.
Section III.A.5 of the draft guidance
provides that if the compounded drug
contains the same active moiety as a
marketed FDA-approved, conditionally
approved, or indexed animal drug or an
FDA-approved human drug but as a
different salt, ester, or other noncovalent
64087
derivative, there is a difference between
the compounded drug and the marketed
FDA-approved, conditionally approved,
or indexed animal drug or FDAapproved human drug that will produce
a clinical difference in the identified
patient. In such a case, the medical
rationale is documented in the
prescription, or if a veterinarian is
compounding the drug, the medical
rationale is noted in the patient’s
medical record. We tentatively conclude
that it is usual and customary for
veterinarians to document their medical
rationale for using such a compounded
product as a matter of maintaining an
adequate medical record in routine
practice; therefore, no burden has been
estimated for the time it would take for
a veterinarian to make this record.
Section III.A.6 of the draft guidance
provides that if the compounded animal
drug has any of the same active
ingredient moiety(ies) as one or more
marketed FDA-approved, conditionally
approved, or indexed animal drugs or
FDA-approved human drugs, the
compounder has determined and
documented the reason(s) why the FDAapproved, conditionally approved, or
indexed animal drug(s) or FDAapproved human drug(s) cannot be used
as the source of the active ingredient(s).
We tentatively conclude that it is not
usual and customary in routine business
practice for a compounder to document
that rationale; therefore, we estimate the
time it would take for a compounder to
make this record, as follows.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Compounder recordkeeping to document the rationale (section III.A.6 of the draft guidance).
7,500
1,360
10,200,000
0.017 (1 minute) ........
173,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
According to the American
Pharmacists Association, of the
approximately 56,000 community-based
pharmacies in the United States, about
7,500 pharmacies specialize in
compounding services.1 We estimate
that veterinarians will write
approximately 11,339,400 prescriptions
for compounded animal drugs annually,
as reported in table 2. Based on our
experience with the regulation of
compounded animal drugs, we estimate
1 American Pharmacists Association, ‘‘Frequently
Asked Questions About Pharmaceutical
Compounding,’’ n.d., https://www.pharmacist.com/
frequently-asked-questions-about-pharmaceuticalcompounding (accessed March 19, 2019).
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that from 75 to 90 percent of these
prescriptions will require the
compounder to document the rationale
described in section III.A.6 of the draft
guidance. Using the upper-bound
estimate of 90 percent, approximately
10,205,460 prescriptions (0.90 ×
11,339,400 prescriptions) will require
compounders to keep the additional
record. Dividing these prescriptions
equally among the approximately 7,500
compounding pharmacies, we estimate
that the 7,500 compounding pharmacies
will, on average, each produce
approximately 1,360 compounded
animal drugs annually for a total of
10,200,000 filled prescriptions. We
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estimate that it will take approximately
1 minute (0.017 hours) to document the
rationale described in section III.A.6 of
the draft guidance for each compounded
animal drug for a total of 173,400 hours,
as reported in table 1.
Section III.C.3 of the draft guidance
provides that if the compounded drug is
compounded for use as an antidote for
food-producing animals, the
veterinarian establishes and documents
a scientifically based withdrawal time
that ensures residues of the antidote and
the underlying toxin are not present in
the animal at the time of slaughter or the
veterinarian ensures the animal does not
enter the food supply. We tentatively
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conclude that it is usual and customary
for veterinarians to establish and
document a scientifically based
withdrawal time as a matter of
maintaining an adequate medical record
in routine practice; therefore, no burden
has been estimated for the time it would
take for a veterinarian to make this
record.
Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary
to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities. As
discussed, we tentatively conclude that
it is usual and customary for
veterinarians to keep, in the normal
course of their activities, the type of
records described in the draft guidance
in sections III.A.4, III.A.5, and III.C.3;
therefore, no burden has been estimated
for such veterinary recordkeeping.
Third-Party Disclosure: Section III.A.3
of the draft guidance provides that the
compounded drug should be dispensed,
after receipt of a prescription for an
identified patient from the veterinarian
acting within a valid veterinarian-clientpatient relationship (VCPR), directly to
the prescribing veterinarian or to the
patient’s owner or caretaker. We
tentatively conclude that it is usual and
customary for veterinarians to write
prescriptions for an identified patient in
the normal course of their activities;
therefore, no burden has been estimated
for the time it would take for a
veterinarian to write a prescription.
However, the draft guidance sets forth
additional third-party disclosure
provisions. Section III.A.4 of the draft
guidance provides: If the compounded
drug is a copy of a marketed FDAapproved, conditionally approved, or
indexed animal drug or an FDAapproved human drug, there is a
difference between the compounded
drug and the FDA-approved,
conditionally approved, or indexed
animal drug or an FDA-approved
human drug that will produce a clinical
difference in the identified patient, ‘‘and
the medical rationale is documented in
the prescription. . . .’’ For example, the
veterinarian could state that, ‘‘The
patient requires a 1.0% solution and the
FDA-approved solution is 0.1%.’’ In
addition, Section III.A.5 of the draft
guidance sets forth the following
additional third-party disclosure
provisions: (1) If the compounded drug
contains the same active moiety as a
marketed FDA-approved, conditionally
approved, or indexed animal drug or an
FDA-approved human drug but as a
different salt, ester, or other noncovalent
derivative; (2) if there is a difference
between the compounded drug and the
marketed FDA-approved, conditionally
approved, or indexed animal drug or
FDA-approved human drug that will
produce a clinical difference in the
identified patient; and (3) ‘‘the medical
rationale is documented in the
prescription. . . .’’ We tentatively
conclude that it is not usual and
customary for veterinarians to include
either one of these medical rationales in
a prescription in the normal course of
their activities; therefore, we estimate
the time it would take for a veterinarian
to add a medical rationale to a
prescription, as follows.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
Statements on prescription (sections III.A.4 and 5
of the draft guidance).
113,394
100
11,339,400
0.017 (1 minute) ........
192,770
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of respondent veterinarians on the
American Veterinary Medical
Association’s Market Research Statistics
for 2018.2 We estimate that
approximately 113,394 veterinarians
will, on average, each produce
approximately 100 prescriptions for
compounded animal drugs annually for
a total of 11,339,400 prescriptions. We
also estimate that it will take
approximately 1 minute (0.017 hours) to
include the statement discussed in
section III.A.5 of the draft guidance on
each prescription for a total of 192,769.8
hours, rounded to 192,770 hours thirdparty disclosure burden, as reported in
table 2.
In addition, the draft guidance
provides for the labeling of animal drugs
compounded from bulk drug
substances. The draft guidance indicates
2 The AVMA’s Market Research Statistics—U.S.
Veterinarians—2018 can be found at this URL:
https://www.avma.org/KB/Resources/Statistics/
Pages/Market-research-statistics-USveterinarians.aspx.
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in sections III.A.8, III.B.6, and III.C.5
that pharmacists and veterinarians
should label the compounded drug with
a variety of information including: (1)
The name of the drug; (2) the strength
of the drug; (3) identifying information
about the patient including the species
of the patient, the name of the patient,
(4) identifier for the individual animal
(e.g., horse in stall X), or identification
of a group of animals (e.g., dogs in
shelter kennel X); (5) indications for
which the drug will be used (for certain
animal drugs without a patient specific
prescription (i.e., office stock) and
compounded drugs for use as antidotes
for food-producing animals); (6) the
name, address, and contact information
for the compounding pharmacy or
compounding veterinarian and name of
prescribing veterinarian (for office stock,
the name, address, and contact
information for the veterinarian
ordering the office stock); (7) the beyond
use date; and (8) for compounded drugs
for use as antidotes for food-producing
animals, the veterinarian-determined
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withdrawal time. We tentatively
conclude that it is usual and customary
for pharmacists and veterinarians to
include such information on the labels
of compounded animal drugs in the
normal course of their activities;
therefore, no burden has been estimated
for the time it would take for such
labeling.
Finally, sections III.A.8 and III.C.5 of
the draft guidance indicates that
pharmacists and veterinarians should
include on the label of any compounded
animal drug from bulk drug substances
these three statements:
• ‘‘Report adverse events to FDA
using online Form FDA 1932a’’;
• ‘‘This is a compounded drug’’; and
• ‘‘Caution: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.’’
Similarly, section III.B.6 of the draft
guidance indicates that pharmacists and
veterinarians should include on the
label of any animal drug compounded
from bulk drug substances as office
stock these four statements:
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• ‘‘Report adverse events to FDA
using online Form FDA 1932a’’;
• ‘‘This is a compounded drug’’;
• ‘‘Not for use in food-producing
animals’’; and
• ‘‘Caution: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.’’
We tentatively conclude that these
label statements are public disclosures
of information originally supplied by
the Federal Government to the recipient
for the purpose of disclosure to the
public (5 CFR 1320.3(c)(2)) and are
therefore not subject to review by OMB
under the PRA. Thus, no burden has
been estimated for the time it would
take for such labeling.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA. The collections of information
regarding voluntary reporting of adverse
drug experiences or product/
manufacturing defects on Form FDA
1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report,’’ have been
approved under OMB control number
0910–0284.
Before the proposed information
collection provisions contained in this
draft guidance become effective, we will
publish a notice in the Federal Register
announcing OMB’s decision to approve,
modify, or disapprove the proposed
information collection provisions. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number.
V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25139 Filed 11–19–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:21 Nov 19, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4187]
A New Era of Smarter Food Safety;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of public meeting and request for
comments that appeared in the Federal
Register of September 18, 2019. The
notice announced a public meeting
entitled ‘‘A New Era of Smarter Food
Safety’’ that was held on October 21,
2019. In the notice of public meeting
and request for comments, FDA
requested comments on a modern
approach the Agency is taking to
strengthen its protection of the food
supply to help shape an FDA blueprint
for a new era of smarter food safety. The
Agency is taking this action in response
to requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the notice published
September 18, 2019 (84 FR 49111).
Submit either electronic or written
comments by December 5, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 5,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 5, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
64089
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–4187 for ‘‘A New Era of
Smarter Food Safety.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64085-64089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4533]
Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of draft guidance for industry (GFI) #256 entitled
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft
guidance, if finalized, will describe FDA's current thinking about
compounding animal drugs from bulk drug substances. FDA has generally
exercised enforcement discretion with regard to animal drug compounding
from bulk drug substances under certain circumstances when no other
medically appropriate treatment options exist. This draft guidance, a
continuation of this practice, is intended to provide additional
information and clarity to veterinarians and pharmacists about FDA's
current thinking with respect to animal drug compounding from bulk drug
substances. FDA previously published draft guidance on this issue for
public comment in May 2015 (Draft GFI #230, ``Compounding Animal Drugs
from Bulk Drug Substances''). We received over 150 comments on that
draft guidance. Based on those comments, we decided to withdraw the May
2015 draft guidance and publish this draft guidance for public comment.
DATES: Submit either electronic or written comments on the draft
guidance by February 18, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the proposed collection of information by February 18, 2020.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-D-4533 for ``Compounding Animal Drugs From Bulk Drug
Substances.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: With regard to this draft guidance:
Eric
[[Page 64086]]
Nelson, Division of Compliance (HFV-230), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-7001, [email protected].
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #256 entitled
``Compounding Animal Drugs from Bulk Drug Substances.'' FDA has
generally exercised enforcement discretion with regard to animal drug
compounding from bulk drug substances under certain circumstances when
no other medically appropriate treatment options exist. This draft
guidance, a continuation of this practice, is intended to provide
additional information and clarity to veterinarians and pharmacists
about FDA's current thinking with respect to animal drug compounding
from bulk drug substances. We previously announced the availability of
a draft guidance addressing this issue (GFI #230, ``Compounding Animal
Drugs from Bulk Drug Substances'') in the Federal Register of May 19,
2015 (80 FR 28624). In response to the comments received on GFI #230,
we decided not to finalize that draft guidance, and instead are issuing
draft GFI #256 for comment. If finalized, this draft guidance will
describe the circumstances under which, based on our current
understanding of the risks of animal drugs compounded from bulk drug
substances, FDA does not intend to take enforcement action against
pharmacies and veterinarians who compound animal drugs for violations
of the FD&C Act's requirements for: (1) Approval; (2) adequate
directions for use; and (3) current good manufacturing practices.
Elsewhere in this issue of the Federal Register, FDA is requesting
nominations for bulk drug substances to be included on the ``List of
Bulk Drug Substances for Compounding Office Stock Drugs for Use in
Nonfood-Producing Animals or Antidotes for Food-Producing Animals''
(the List) described in draft GFI #256. That Federal Register notice
describes information needed by FDA to evaluate nominations and
explains when FDA will include bulk drug substances on the List; such
nominations will be collected in a separate docket. The List is
available at https://wcms.fda.gov/FDAgov/AnimalVeterinary/ComplianceEnforcement/UnapprovedAnimalDrugs/ucm596211.htm.
II. Specific Topic for Comment
In addition to any other comments on the draft guidance, we are
specifically requesting comments on section III.A.5 of the draft
guidance. That section provides that if a compounded drug contains the
same active moiety as a marketed FDA-approved, conditionally approved,
or indexed animal drug or an FDA-approved human drug but as a different
salt, ester, or other noncovalent derivative, there should be a
difference between the compounded drug and the FDA-approved,
conditionally approved, or indexed animal drug or FDA-approved human
drug that will produce a clinical difference in the patient and the
medical rationale is documented in the prescription, or if a
veterinarian is compounding the drug, the medical rationale is noted in
the patient's medical record.
FDA is concerned that compounding an animal drug using a different
salt, ester, or other noncovalent derivative of the same active moiety
used in a marketed FDA-approved, conditionally approved, or indexed
animal drug or FDA-approved human drug can affect the absorption,
distribution, metabolism, excretion, and stability of the compounded
animal drug. All of these factors contribute to a drug's safety and
effectiveness.
FDA is also concerned that compounding an animal drug from a
different salt, ester, or other noncovalent derivative of the same
active moiety as a marketed FDA-approved, conditionally approved, or
indexed animal drug or FDA-approved human drug may impact the
incentives for seeking legal marketing status of a new animal drug
(i.e., approval, conditional approval, or indexing). Unlimited
compounding using a different salt, ester, or other noncovalent
derivative could cause a disincentive for new animal drug sponsors to
continue to research and develop innovative new animal drugs.
However, FDA believes that in some cases the prescribing
veterinarian may determine that a new animal drug from a different
salt, ester, or other noncovalent derivative of the same active moiety
as a marketed FDA-approved, conditionally approved, or indexed animal
drug or FDA-approved human drug will produce a clinical difference for
the identified patient. Under the draft guidance, a pharmacy could
compound such an animal drug if the prescribing veterinarian documents
such a determination on the prescription, or if a veterinarian is
compounding the drug, the medical rationale is noted in the patient's
medical record.
FDA invites public comment on this issue.
III. Significance of Guidance
This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
if finalized, will represent the current thinking of FDA on compounding
animal drugs from bulk drug substances. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations
IV. Paperwork Reduction Act of 1995
This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3521). ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, we invite comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information collected; and (4)
ways to minimize the burden of the information collected on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Compounding Animal Drugs from Bulk Drug Substances (OMB
Control Number 0910-NEW).
Description of Respondents: The proposed respondents are
pharmacists
[[Page 64087]]
in either State-licensed pharmacies or Federal facilities, or
veterinarians, who compound animal drugs from bulk drug substances.
Description: The Center for Veterinary Medicine has written draft
GFI #256 to address a perceived need for Agency guidance in its work
with the animal health industry. The draft guidance describes FDA's
current thinking, based on our current understanding of the risks of
animal drugs compounded from bulk drug substances, and describes the
circumstances under which FDA does not intend to take enforcement
action against pharmacists and veterinarians who compound animal drugs
from bulk drug substances.
FDA estimates the burden of this collection of information as
follows:
Reporting: The draft guidance contains no new reporting provisions.
Recordkeeping: The draft guidance contains a new recordkeeping
provision. Our exercise of discretion is dependent upon our ability to
assess whether the circumstances under which FDA would intend to
exercise such discretion, as described in this draft guidance, exist.
FDA staff may use pharmacy and veterinary records, among other things,
to determine the circumstances surrounding the compounding activity.
Except with regard to one proposed item, the routine business records
kept by pharmacists who compound animal drugs from bulk drug substances
and veterinarians who compound animal drugs from bulk drug substances,
as well as veterinarians prescribing compounded animal drugs within a
valid veterinarian-client-patient relationship, should be adequate to
demonstrate that the circumstances described in the draft guidance
exist.
The draft guidance sets forth circumstances for the compounding of
animal drugs from bulk drug substances. Section III.A.4 of the draft
guidance provides that if the compounded drug is a copy of a marketed
FDA-approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug, there is a difference between the compounded drug
and the FDA-approved, conditionally approved, or indexed animal drug or
the FDA-approved human drug that will produce a clinical difference in
the identified patient and the medical rationale is documented in the
prescription, or if a veterinarian is compounding the drug, the medical
rationale is noted in the patient's medical record. We tentatively
conclude that it is usual and customary for veterinarians to document
their medical rationale for using such a compounded product as a matter
of maintaining an adequate medical record in routine practice;
therefore, no burden has been estimated for the time it would take for
a veterinarian to make this record.
Section III.A.5 of the draft guidance provides that if the
compounded drug contains the same active moiety as a marketed FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug but as a different salt, ester, or other
noncovalent derivative, there is a difference between the compounded
drug and the marketed FDA-approved, conditionally approved, or indexed
animal drug or FDA-approved human drug that will produce a clinical
difference in the identified patient. In such a case, the medical
rationale is documented in the prescription, or if a veterinarian is
compounding the drug, the medical rationale is noted in the patient's
medical record. We tentatively conclude that it is usual and customary
for veterinarians to document their medical rationale for using such a
compounded product as a matter of maintaining an adequate medical
record in routine practice; therefore, no burden has been estimated for
the time it would take for a veterinarian to make this record.
Section III.A.6 of the draft guidance provides that if the
compounded animal drug has any of the same active ingredient
moiety(ies) as one or more marketed FDA-approved, conditionally
approved, or indexed animal drugs or FDA-approved human drugs, the
compounder has determined and documented the reason(s) why the FDA-
approved, conditionally approved, or indexed animal drug(s) or FDA-
approved human drug(s) cannot be used as the source of the active
ingredient(s). We tentatively conclude that it is not usual and
customary in routine business practice for a compounder to document
that rationale; therefore, we estimate the time it would take for a
compounder to make this record, as follows.
Table 1--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compounder recordkeeping to document the 7,500 1,360 10,200,000 0.017 (1 minute)........................ 173,400
rationale (section III.A.6 of the draft
guidance).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
According to the American Pharmacists Association, of the
approximately 56,000 community-based pharmacies in the United States,
about 7,500 pharmacies specialize in compounding services.\1\ We
estimate that veterinarians will write approximately 11,339,400
prescriptions for compounded animal drugs annually, as reported in
table 2. Based on our experience with the regulation of compounded
animal drugs, we estimate that from 75 to 90 percent of these
prescriptions will require the compounder to document the rationale
described in section III.A.6 of the draft guidance. Using the upper-
bound estimate of 90 percent, approximately 10,205,460 prescriptions
(0.90 x 11,339,400 prescriptions) will require compounders to keep the
additional record. Dividing these prescriptions equally among the
approximately 7,500 compounding pharmacies, we estimate that the 7,500
compounding pharmacies will, on average, each produce approximately
1,360 compounded animal drugs annually for a total of 10,200,000 filled
prescriptions. We estimate that it will take approximately 1 minute
(0.017 hours) to document the rationale described in section III.A.6 of
the draft guidance for each compounded animal drug for a total of
173,400 hours, as reported in table 1.
---------------------------------------------------------------------------
\1\ American Pharmacists Association, ``Frequently Asked
Questions About Pharmaceutical Compounding,'' n.d., https://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding (accessed March 19, 2019).
---------------------------------------------------------------------------
Section III.C.3 of the draft guidance provides that if the
compounded drug is compounded for use as an antidote for food-producing
animals, the veterinarian establishes and documents a scientifically
based withdrawal time that ensures residues of the antidote and the
underlying toxin are not present in the animal at the time of slaughter
or the veterinarian ensures the animal does not enter the food supply.
We tentatively
[[Page 64088]]
conclude that it is usual and customary for veterinarians to establish
and document a scientifically based withdrawal time as a matter of
maintaining an adequate medical record in routine practice; therefore,
no burden has been estimated for the time it would take for a
veterinarian to make this record.
Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources
necessary to comply with a collection of information are excluded from
the burden estimate if the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary because they would
occur in the normal course of activities. As discussed, we tentatively
conclude that it is usual and customary for veterinarians to keep, in
the normal course of their activities, the type of records described in
the draft guidance in sections III.A.4, III.A.5, and III.C.3;
therefore, no burden has been estimated for such veterinary
recordkeeping.
Third-Party Disclosure: Section III.A.3 of the draft guidance
provides that the compounded drug should be dispensed, after receipt of
a prescription for an identified patient from the veterinarian acting
within a valid veterinarian-client-patient relationship (VCPR),
directly to the prescribing veterinarian or to the patient's owner or
caretaker. We tentatively conclude that it is usual and customary for
veterinarians to write prescriptions for an identified patient in the
normal course of their activities; therefore, no burden has been
estimated for the time it would take for a veterinarian to write a
prescription.
However, the draft guidance sets forth additional third-party
disclosure provisions. Section III.A.4 of the draft guidance provides:
If the compounded drug is a copy of a marketed FDA-approved,
conditionally approved, or indexed animal drug or an FDA-approved human
drug, there is a difference between the compounded drug and the FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug that will produce a clinical difference in the
identified patient, ``and the medical rationale is documented in the
prescription. . . .'' For example, the veterinarian could state that,
``The patient requires a 1.0% solution and the FDA-approved solution is
0.1%.'' In addition, Section III.A.5 of the draft guidance sets forth
the following additional third-party disclosure provisions: (1) If the
compounded drug contains the same active moiety as a marketed FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug but as a different salt, ester, or other
noncovalent derivative; (2) if there is a difference between the
compounded drug and the marketed FDA-approved, conditionally approved,
or indexed animal drug or FDA-approved human drug that will produce a
clinical difference in the identified patient; and (3) ``the medical
rationale is documented in the prescription. . . .'' We tentatively
conclude that it is not usual and customary for veterinarians to
include either one of these medical rationales in a prescription in the
normal course of their activities; therefore, we estimate the time it
would take for a veterinarian to add a medical rationale to a
prescription, as follows.
Table 2--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statements on prescription (sections 113,394 100 11,339,400 0.017 (1 minute)........................ 192,770
III.A.4 and 5 of the draft guidance).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number of respondent veterinarians on
the American Veterinary Medical Association's Market Research
Statistics for 2018.\2\ We estimate that approximately 113,394
veterinarians will, on average, each produce approximately 100
prescriptions for compounded animal drugs annually for a total of
11,339,400 prescriptions. We also estimate that it will take
approximately 1 minute (0.017 hours) to include the statement discussed
in section III.A.5 of the draft guidance on each prescription for a
total of 192,769.8 hours, rounded to 192,770 hours third-party
disclosure burden, as reported in table 2.
---------------------------------------------------------------------------
\2\ The AVMA's Market Research Statistics--U.S. Veterinarians--
2018 can be found at this URL: https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-veterinarians.aspx.
---------------------------------------------------------------------------
In addition, the draft guidance provides for the labeling of animal
drugs compounded from bulk drug substances. The draft guidance
indicates in sections III.A.8, III.B.6, and III.C.5 that pharmacists
and veterinarians should label the compounded drug with a variety of
information including: (1) The name of the drug; (2) the strength of
the drug; (3) identifying information about the patient including the
species of the patient, the name of the patient, (4) identifier for the
individual animal (e.g., horse in stall X), or identification of a
group of animals (e.g., dogs in shelter kennel X); (5) indications for
which the drug will be used (for certain animal drugs without a patient
specific prescription (i.e., office stock) and compounded drugs for use
as antidotes for food-producing animals); (6) the name, address, and
contact information for the compounding pharmacy or compounding
veterinarian and name of prescribing veterinarian (for office stock,
the name, address, and contact information for the veterinarian
ordering the office stock); (7) the beyond use date; and (8) for
compounded drugs for use as antidotes for food-producing animals, the
veterinarian-determined withdrawal time. We tentatively conclude that
it is usual and customary for pharmacists and veterinarians to include
such information on the labels of compounded animal drugs in the normal
course of their activities; therefore, no burden has been estimated for
the time it would take for such labeling.
Finally, sections III.A.8 and III.C.5 of the draft guidance
indicates that pharmacists and veterinarians should include on the
label of any compounded animal drug from bulk drug substances these
three statements:
``Report adverse events to FDA using online Form FDA
1932a'';
``This is a compounded drug''; and
``Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.''
Similarly, section III.B.6 of the draft guidance indicates that
pharmacists and veterinarians should include on the label of any animal
drug compounded from bulk drug substances as office stock these four
statements:
[[Page 64089]]
``Report adverse events to FDA using online Form FDA
1932a'';
``This is a compounded drug'';
``Not for use in food-producing animals''; and
``Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.''
We tentatively conclude that these label statements are public
disclosures of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
(5 CFR 1320.3(c)(2)) and are therefore not subject to review by OMB
under the PRA. Thus, no burden has been estimated for the time it would
take for such labeling.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by OMB under the PRA. The collections
of information regarding voluntary reporting of adverse drug
experiences or product/manufacturing defects on Form FDA 1932a,
``Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product
Defect Report,'' have been approved under OMB control number 0910-0284.
Before the proposed information collection provisions contained in
this draft guidance become effective, we will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the proposed information collection provisions. An Agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
V. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25139 Filed 11-19-19; 8:45 am]
BILLING CODE 4164-01-P
